Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr M S de Bruin-Weller
ORCID ID
Contact details
University Medical Center Utrecht
Department of Dermatology
HPN G02 124
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509111
m.s.debruin-weller@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14196
Study information
Scientific title
Acronym
Effect of Myfortic® on UV-induced DNA-damage and atopic status
Study hypothesis
Our hypothesis is that in patients with atopic dermatitis which use topical tacrolimus 0.1% the repair of DeoxyriboNucleic Acid (DNA)-damage in the skin is delayed. The repair of DNA-damage in the skin of patients with atopic dermatitis which use a class II corticosteroid is not delayed.
Ethics approval
Not provided at time of registration
Study design
Clinical Trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Atopic dermatitis
Intervention
Ten patients in total with atopic dermatitis are to be included in the study. The inclusion takes place after the physician has indicated that treatment with oral immunosuppressive drugs is necessary. The informed consent intake will be performed by the researcher. At inclusion a screening will be done to evaluate the severity of the eczema and the atopic state (total and specific Immunoglobulin E [IgE], skin-prick test and atopy patch test) of the patient.
Subsequently we will compare UV-irradiated, non-lesional skin prior to treatment (control) to UV-irradiated, non-lesional skin treated with Myfortic® during 12 weeks (intervention). The Minimal Erythema Dose (MED) will be determined prior to actual irradiation. Punch biopsies will be taken immediately after irradiation with two MED and after 24 hours. A reference biopsy will be taken from skin that is not irrradiated. The whole process will be repeated after 12 weeks of treatment.
To evaluate the atopic status after 12 weeks of treatment, we will repeat the skin-prick test and atopy patch test. The final clinical evaluation of therapy will be performed after 16 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Myfortic®
Primary outcome measures
The difference between the percentage in repair of Cyclobutane Pyrimidine Dimers (CPD's) before and after treatment with Myfortic® is the primary study outcome.
Secondary outcome measures
1. The atopic state before and after treatment with Myfortic®.
2. The evaluation of the efficacy of initial high dosing with Myfortic® in order to induce rapid improvement of the disease.
Overall trial start date
01/10/2006
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age from 18 years
2. Atopic dermatitis according to the criteria of Hanifin and Rajka
3. Insufficient response to topical therapy alone
4. The physician estimates that treatment with oral immunosuppressive agents is indicated
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
10
Participant exclusion criteria
1. Patients with any known hypersensitivity to mycofenolic acid or other components of the formulation
2. Oral immunosuppressive treatment in the last six weeks
3. Concomitant Ultraviolet (UV) therapy or UV therapy in the last two months
4. Contact with UV on the lesional skin for the last two months
5. Patients with thrombocytopenia (less than 75,000/mm^3), with an absolute neutrophil count less than 1,500/mm^3 and/or leukocytopenia (less than 2,500/mm^3) and/or haemoglobin less than 6.0 g/dl prior to enrolment
6. Patients who have received an investigational drug within two weeks prior to screening
7. Patients with a history of malignancy within the last five years
8. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
9. Patients with an immunologic disorder (like Rheumatoid Arthritis [RA], Systemic Lupus Erythematosus [SLE] or M. SjÖgren) or a pre-existent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema)
10. Presence of clinically significant infection requiring continued therapy, severe diarrhoea or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study
Recruitment start date
01/10/2006
Recruitment end date
01/05/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Funders
Funder type
Industry
Funder name
Novartis Pharma B.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary